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Cefuroxime Mylan

Mylan Hospital

Pulver till injektionsvätska, lösning/suspension 250 mg
Avregistreringsdatum: 2016-06-30 (Tillhandahålls ej)

Aktiv substans:
ATC-kod: J01DC02
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
Läs mer om avregistrerade läkemedel

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för cefuroxim är framtagen av företaget GlaxoSmithKline för Zinacef, Zinacef (Monovial), Zinacef®, Zinnat®

Miljörisk: Användning av cefuroxim har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Cefuroxim är potentiellt persistent.
Bioackumulering: Cefuroxim har låg potential att bioackumuleras.


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Detaljerad miljöinformation


Detailed background information


Environmental Risk Classification


Predicted Environmental Concentration (PEC)


PEC is calculated according to the following formula:


PEC (μg/L) = (A*109*(100-R)/(365*P*V*D*100) = 1.5*10-6*A(100-R)


PEC = 0.019 μg/L


Where:

A = 124.64 kg (total sold amount API in Sweden year 2018, data from IQVIA Health).


R = 0% removal rate (conservatively, it has been assumed there is no loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 9 *106


V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference 1)


D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Reference 1)


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Green Algae (Selenastrum caprocornutum):

IC50 72h (inhibition of growth rate) > 76,000 μg/L (OECD 201) (Reference 3)

NOEC = 76,000 μg/L


Blue-green Algae (Anabaena flos-aquae)

EC50 72h (inhibition of growth rate) = 35 μg/L (OECD 201) (Reference 4)

EC10 = 17 μg/L


Water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) > 831,000 μg/L (OECD 202) (Reference 3)

NOEC = 831,000 μg/L


Rainbow Trout (Oncorhyncus mykiss):

Acute toxicity

LC50 96 h (lethality) > 100,000 μg/L (OECD 203) (Reference 3)

NOEC = 100,000 μg/L


Other ecotoxicity data:


Microorganisms in activated sludge

EC50 3 hours (Inhibition) > 688,000 μg/L (OECD 209) (Reference 3)

NOEC = 688,000 μg/L


PNEC = 17/10 = 1.7 μg/L


PNEC (μg/L) = EC10/10, where 10 is the assessment factor recommended for the anti‑microbial study effect (EC10) with cyanobacteria (Reference 5). The EC10 for blue green algae (= 17 µg/L) has been used for this calculation.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.019/1.70 = 0.011, i.e. PEC/PNEC ≤ 1 which justifies the phrase “Use of cefuroxime has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation

Ready degradability:

28% degradation in 28 days (OECD 301B) (Reference 3)

42% degradation in 64 days


Inherent degradability:

74% primary (loss of parent) degradation in 28 days (OECD 302B) (Reference 3)


Abiotic degradation


Hydrolysis:

Half-life, pH 7 = 30 hrs, (OECD 111) (Reference 3)

Half-life, pH 5 = 299 hrs.

Half-life, pH 9 = 1 hrs.


Photolysis:

No data


Justification of chosen degradation phrase:

Cefuroxime is not readily biodegradable nor inherently biodegradable. The phrase “Cefuroxime is potentially persistent” is thus chosen.


Bioaccumulation


Partitioning coefficient:

Log Dow = 0.80 at pH7. (TAD 3.02) (Reference 3)


Log Dow at pH5 = 1.24

Log Dow at pH7 = 0.80


Justification of chosen bioaccumulation phrase:

Since log Dow < 4, the substance has low potential for bioaccumulation.


Excretion (metabolism)


Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion. (Reference 2)


PBT/vPvB assessment

Cefuroxime does not fulfil the criteria for PBT and/or vBvP.


All three properties, i.e. ‘P’, ‘B’ and ‘T’ are required in order to classify a compound as PBT (Reference 1). Cefuroxime does not fulfil the criteria for PBT and/or vBvP based on a log Dow < 4.


Please, also see Safety data sheets onhttp://www.msds-gsk.com/ExtMSDSlist.asp


References


  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.


  2. Pharmacokinetic properties: Metabolism and Elimination. Summary of Product Characteristics Zinnat (Cefuroxime) Suspension. GlaxoSmithKline, July2008.


  3. Material Safety Data Sheet for Zinnat (Cefuroxime) tablets. SDS number 110539. GlaxoSmithKline plc, July 2008.


  4. Vryenhoef H. Cefuroxime Sodium: Algal Growth Inhibition Test. Report No. BG81VW. Envigo Research Limited, August 2018.


  5. EMA Q&A for Environmental Risk Assessment http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/04/WC500105107.pdf